- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01639560
Varenicline for Light Smokers (ChanLight)
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subjects must be ≥ 18 years of age;
- smokes 5 to 10 CPD for at least 6 months;
- express interest in quitting smoking;
- indicate ability to complete all study visits; and
- provide written informed consent to participate in the study.
- Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
- Subject is in good health as determined by the investigator;
- Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments.
Exclusion Criteria:
- An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;
- History of renal failure;
- Cancer [excluding non-melanoma skin cancer] not in remission;
- Psychosis or bipolar disorder;
- Current unstable or untreated moderate or severe depression as assessed by the CES-D;
- have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.");
Substance dependence other than nicotine, defined as:
a. Patient has a recent history (past month) of heavy alcohol consumption as defined by NIAAA: i. Men: More than 4 drinks on any day or 14 per week ii. Women: More than 3 drinks on any day or 7 per week. b. Use of cocaine, heroin, club drugs (i.e., MDMA/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past month.
c. Use of marijuana on a weekly basis for the past month
- An allergy to varenicline;
- Current use of a behavioral or pharmacologic tobacco dependence treatment and unwilling or unable to discontinue use;
- Another member of their household already participating in this study; and
- Current treatment with another investigational drug (within 30 days of study entry).
- Has an unstable medical condition;
- Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
- Women of child-bearing potential, or who are pregnant, lactating or likely to become pregnant during the trial and are unwilling to use an acceptable form of contraception during the medication phase will also be excluded. All female subjects of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during participation in the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Varenicline
1 mg of varenicline twice per day for 12 weeks.
|
1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling
Altri nomi:
|
|
Comparatore placebo: placebo
1 placebo tablet twice a day for 12 weeks
|
1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
Lasso di tempo: 12 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers.
Point prevalence is defined as no smoking in the past 7 days.
|
12 weeks
|
|
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
Lasso di tempo: 12 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers.
Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
|
12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
Lasso di tempo: 24 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers.
Point prevalence is defined as no smoking in the past 7 days.
|
24 weeks
|
|
Prolonged Smoking Outcome at 24 Weeks (End of Study)
Lasso di tempo: 24 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers.
Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
|
24 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Ivana T. Croghan, PhD, Mayo Clinic
- Investigatore principale: Jon O. Ebbert, MD, Mayo Clinic
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12-005652
- WS2293926 (Altro numero di sovvenzione/finanziamento: Pfizer Inc)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .